TPLC - Total Product Life Cycle

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Device	coagulator-cutter, endoscopic, unipolar (and accessories)
Product Code	KNF
Regulation Number	884.4160
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	20	20
Material Separation	18	18
Detachment of Device or Device Component	11	11
Sparking	4	4
Insufficient Information	4	4
Melted	4	4
Fire	3	3
Smoking	3	3
Material Fragmentation	3	3
Failure to Cut	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Fracture	3	3
Improper or Incorrect Procedure or Method	3	3
Fitting Problem	2	2
Material Integrity Problem	2	2
Material Twisted/Bent	2	2
Overheating of Device	2	2
Temperature Problem	2	2
Material Frayed	1	1
Separation Problem	1	1
Mechanical Problem	1	1
Physical Resistance/Sticking	1	1
Crack	1	1
Patient-Device Incompatibility	1	1
Defective Component	1	1
Difficult to Remove	1	1
Patient Device Interaction Problem	1	1
Material Rupture	1	1
Material Deformation	1	1
Product Quality Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Difficult to Open or Close	1	1
Therapy Delivered to Incorrect Body Area	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	36	36
No Consequences Or Impact To Patient	19	19
No Known Impact Or Consequence To Patient	7	7
Insufficient Information	7	7
Partial thickness (Second Degree) Burn	6	6
Burn(s)	5	5
Foreign Body In Patient	5	5
Hemorrhage/Bleeding	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Unspecified Reproductive System or Breast Problem	2	2
Patient Problem/Medical Problem	1	1
Electric Shock	1	1
Injury	1	1
No Patient Involvement	1	1
Laceration(s)	1	1
Hormonal Imbalance	1	1
Liver Laceration(s)	1	1
Device Embedded In Tissue or Plaque	1	1